Pyramid Consulting, Inc
CMC Regulatory Technical Writer II
Pyramid Consulting, Inc, Bridgewater, New Jersey, us, 08807
Immediate need for a talented
CMC Regulatory Technical Writer II
. This is a
12+ Months Contract
opportunity with long-term potential and is located in
Bridgewater, NJ - 08807, and Boston, MA 02141(Hybrid) . Please review the job description below and contact me ASAP if you are interested.
Job ID:24-29905
Pay Range: $45 - $50/hour.
Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Notes:
Open to local candidates only NJ candidates: hybrid schedule (2x week) Boston candidates: in-person training, fully remote after
Education: minimum qualification is a Bachelors in Biology, or Pharmacy.
Must-Have Experience with: VEEVA, life-cycle tools, MS Suite especially Word & Excel.
Preferred experience: Regulatory affairs • Work Experience: 5 years of industry experience.
Key Responsibilities:
The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
He/She/They identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
He/she/they authors autonomously the CMC sections of dossiers using Client templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards.
He/She/they ensures delivery of sections in a timely manner.
He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
He/she/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
He/She/They maintains an up to date knowledge of Client's ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
He/She/They also authors other types of regulatory documents such as white papers, position papers, and briefing book.
In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
Key Requirements and Technology Experience:
The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
The candidate must have CTD Module 3 authoring skills.
A background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
The candidate must have at least 5 years' experience in the pharmaceutical industry.
Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus.
A working knowledge of cGMP’s is desired.
Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.
Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team.
The candidate needs very little supervision, is capable of managing their priorities independently, is highly organized, and self-motivated.
The candidate should enjoy writing. Knowledge of US pharmaceutical Regulations is essential.
Exposure to ex-US Regulations is desired, but not mandatory.
BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
Our client is a leading
Healthcare Industry
and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
#Mor2
CMC Regulatory Technical Writer II
. This is a
12+ Months Contract
opportunity with long-term potential and is located in
Bridgewater, NJ - 08807, and Boston, MA 02141(Hybrid) . Please review the job description below and contact me ASAP if you are interested.
Job ID:24-29905
Pay Range: $45 - $50/hour.
Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Notes:
Open to local candidates only NJ candidates: hybrid schedule (2x week) Boston candidates: in-person training, fully remote after
Education: minimum qualification is a Bachelors in Biology, or Pharmacy.
Must-Have Experience with: VEEVA, life-cycle tools, MS Suite especially Word & Excel.
Preferred experience: Regulatory affairs • Work Experience: 5 years of industry experience.
Key Responsibilities:
The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
He/She/They identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
He/she/they authors autonomously the CMC sections of dossiers using Client templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards.
He/She/they ensures delivery of sections in a timely manner.
He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
He/she/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
He/She/They maintains an up to date knowledge of Client's ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
He/She/They also authors other types of regulatory documents such as white papers, position papers, and briefing book.
In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
Key Requirements and Technology Experience:
The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
The candidate must have CTD Module 3 authoring skills.
A background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
The candidate must have at least 5 years' experience in the pharmaceutical industry.
Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus.
A working knowledge of cGMP’s is desired.
Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.
Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team.
The candidate needs very little supervision, is capable of managing their priorities independently, is highly organized, and self-motivated.
The candidate should enjoy writing. Knowledge of US pharmaceutical Regulations is essential.
Exposure to ex-US Regulations is desired, but not mandatory.
BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
Our client is a leading
Healthcare Industry
and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
#Mor2